Status:
COMPLETED
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion
- Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:
- Biopsy OR
- Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
- Blood test positive for Hepatitis B or C AND
- Alpha fetoprotein above \> 400 mg/L
- Not appropriate for curative surgery
- Screening Blood Pressure \<150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) \>50%
Exclusion
- Heart Attack within 12 months, uncontrolled chest pain within 6 months
- Ascites resistant to diuretic medication therapy
- Portal-systemic encephalopathy
- Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
- Deficiency of sodium in the blood with sodium \< 125 mEq/L
- Subjects with serious non-healing wounds, ulcers or bone fractures
Key Trial Info
Start Date :
December 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2010
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00355238
Start Date
December 31 2006
End Date
April 30 2010
Last Update
December 1 2023
Active Locations (37)
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1
City Of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
City Of Hope National Medical Center
Duarte, California, United States, 91010
3
Harbor UCLA Medical Center
Los Angeles, California, United States, 90095-1678
4
Harbor-Ucla Medical Center
Los Angeles, California, United States, 90095